Pharmaceutical Manufacturing ·
AIM INTELLIX GLOBAL SERVICE Pvt. Ltd. provides comprehensive end-to-end consultancy services for pharmaceutical facilities, supporting companies in achieving and maintaining compliance with international regulatory standards such as EU-GMP, USFDA, PIC/S, TGA, and UK MHRA. End-to-end regulatory support including preparation, review, and submission of dossiers across global markets (USFDA, EU, UK, ASEAN, LATAM, CIS, MEA, and Africa) for OSD, injectable, and biological products. Lifecycle management (variations, renewals). In addition, the company provides Gap Audits, Vendor Audit Support, Dossier Submission Assistance, and Plant Design/Layout Review to ensure facilities are designed and operated in full compliance with regulatory expectations (General, Oncology, and Hormonal Plant). Their expertise covers a wide range of pharmaceutical manufacturing platforms, including Vial Lines, Ampoule Lines, Eye Drop Lines, Lyophilized Products, Prefilled Syringes (PFS), Blow-Fill-Seal (BFS), Oral Solid Dosage (OSD-Tablet, Capsule- Hardgel & Softgel, Liquid), Biological, and other allied dosage forms. By offering complete regulatory, quality, validation, and compliance solutions under one roof, AIM INTELLIX enables clients to access all required pharmaceutical consultancy services in a single basket—simplifying operations and ensuring efficient regulatory compliance. someother services : Preparation, review, and submission of dossiers across global markets (USFDA, EU, UK, ASEAN, LATAM, CIS, MEA, and Africa, GCC) Brownfield & Greenfield Facility Assessment (Existing Plant) Qualification and Validation Risk Assessment, CAPA Aseptic Process validation Audit and Inspection Readiness Quality Management System (QMS) Audit-GMP, GDP, GLP, FAT, Gap Assessment audit Training on QMS, Qualification & Validation, Aseptic Practices, Regulatory & Guideline, CTD, eCTD, ACTD, Product life cycle management.